Verification and Validation Services

Future_Laboratory

We provide you documented evidence that predetermined requirements are consistently met. By examination and the provision of objective evidence we confirm that specified requirements are met.

Have your product CE/IVD marked or FDA Approved

puzzelstuk

 

Advantages

  • Get your product CE/IVD/FDA ready
  • Minimal involvement required from your own R&D team
  • Work with our dedicated, highly experienced teams
  • Future Diagnostics is an independent party
  • If desired transferable to our manufacturing
  • Free up your own R&D team to initiate new developments

puzzelstuk

 

Support

  • Write and approve validation protocols, according to regulatory guidelines (i.e. CLSI)
  • Perform testing and analyze obtained data
  • Write up validation reports
  • Completion of the design history file
  • Collecting necessary validation samples